Safety and efficacy of Dupixent® (dupilumab) in patients as young as 6 years with moderate-to-severe atopic dermatitis further reinforced by new data analyses presented at EADV
- Three-year efficacy and safety follow-up from Phase 3 trial in adults is the longest for any approved systemic therapy in atopic dermatitis
- Additional data evaluated effect of Dupixent on disease severity, itch, and sleep disturbance starting two weeks after first dose in adolescents and children as young as 6 years
- Dupixent has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation
PARIS and TARRYTOWN, N.Y. – October 29, 2020 – New analyses of Phase 3 Dupixent® (dupilumab) data in adults, adolescents, and children with atopic dermatitis will be presented at the 2020 European Academy of Dermatology and Venereology (EADV) Virtual Congress from October 29-31.
Presentations include data from open-label extension trials evaluating laboratory assessments in adults treated with Dupixent for up to three years and adolescents (aged 12 to 17 years) treated up to one year. These data reinforce the well-established long-term safety profile of Dupixent in moderate-to-severe atopic dermatitis, which does not require initial blood testing or ongoing laboratory monitoring.
Additionally, data will be presented from trials that assessed the impact of Dupixent, measured as early as 2 weeks after the first dose, on signs and symptoms including itch, oozing/crusting, swelling and sleep disturbance, using SCOring Atopic Dermatitis (SCORAD) in adolescents with moderate-to-severe disease and children (aged 6 to 11 years) with severe disease.
“Our new data at EADV build on the existing wealth of evidence supporting the unique way Dupixent specifically targets the underlying type 2 inflammation that contributes to diseases like atopic dermatitis, thus significantly improving itch and skin lesions and other important measures that impact a patient’s quality of life,” said Paul Rowe, MD, ATSF, Vice President, Head of Global Medical, Immunology at Sanofi Genzyme. “We will also present data from the adult trial showing how the majority of patients reported high satisfaction with Dupixent after long-term treatment up to three years, which is very important when treating a life-long chronic disease like atopic dermatitis.”
Sanofi and Regeneron joint presentations at EADV will be available starting October 29 at 7 a.m. CET and include:
- Laboratory safety
- P0234: Laboratory Safety of Dupilumab in Pediatric Patients aged ≥ 6 to < 12 years with Severe Atopic Dermatitis: Results from a Phase III Trial (LIBERTY AD PEDS), Andreas Wollenberg
- P0229: Laboratory Safety of Dupilumab in Adolescent Patients with Atopic Dermatitis: 52-Week Laboratory Safety Findings From an Open-Label Study (LIBERTY AD PED-OLE), Michael J. Cork
- P0262: Laboratory Safety of Long-Term Dupilumab Treatment for up to 3 Years in Adults with Moderate-to-Severe Atopic Dermatitis (LIBERTY AD OLE), Andreas Wollenberg
- Long-term results and patient satisfaction
- P0250: High Incidence of Treatment Satisfaction with Long-Term Dupilumab Treatment in Adult Patients With Moderate-to-Severe Atopic Dermatitis (LIBERTY AD OLE), Diamant Thaçi
- Disease signs and symptoms
- P0237: Dupilumab in Children Aged ≥ 6 to < 12 Years Significantly Improves Symptoms of Atopic Dermatitis Assessed by SCORAD (LIBERTY AD PEDS), Sebastien Barbarot
- P0266: Dupilumab Improves Signs and Symptoms Assessed by SCORAD in Adolescents with Moderate-to-Severe Atopic Dermatitis, Ulrike Blume-Peytavi
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Dupixent is approved for adolescents and adults with moderate-to-severe atopic dermatitis, asthma and/or in adults with CRSwNP in a number of countries around the world, including the EU and Japan, as well as the U.S. where Dupixent is also approved for children with moderate-to-severe atopic dermatitis. Dupixent is currently approved in more than 60 countries, and more than 190,000 patients have been treated globally.
Dupilumab development program
To date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation.
In addition to the currently approved indications, Sanofi and Regeneron are also studying dupilumab in a broad range of diseases driven by type 2 inflammation and other allergic processes, including pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), pediatric asthma (6 to 11 years of age, Phase 3), eosinophilic esophagitis (Phase 3), chronic obstructive pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and food and environmental allergies (Phase 2). These potential uses are investigational, and the safety and efficacy of dupilumab in these conditions have not been evaluated by any regulatory authority. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
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